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Doxylamine succinate preparation method

A technology of doxylamine succinate and succinic acid is applied in the field of preparation of antihistamine drug doxylamine succinate, and the effect of simple operation is achieved

Inactive Publication Date: 2017-08-29
NANJING NONGKANG BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In order to overcome the difficulties and deficiencies in the prior art, the inventors have found through a large number of experiments: adding an auxiliary base in the recrystallization process of the crude product of doxylamine succinate can prepare polysuccinic acid with melting point and content meeting the requirements of the drug quality standard. siramine

Method used

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  • Doxylamine succinate preparation method

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Effect test

Embodiment 1

[0023] Doxylamine succinate crude product 2.0g, acetone 8g, triethylamine 0.11g, heated under stirring to dissolve completely, then placed at 10°C-20°C for crystallization, filtered, and vacuum dried at 50°C to obtain white crystalline doxylamine succinate Sirilamine 1.46g, melting point 103.6-104.1°C, content 99.5%.

Embodiment 2

[0025] Doxylamine succinate crude product 2.0g, absolute ethanol 5g, diisopropylamine 0.3g, fully dissolved by heating under stirring, then placed at 10°C-20°C for crystallization, filtered, and vacuum dried at 50°C to obtain white crystalline amber Doxylamine acid 1.25g, melting point 103.2-104.3°C, content 99.3%.

Embodiment 3

[0027] 5.0g of crude doxylamine succinate, 20g of n-butanol, 0.8g of N,N-dimethyl-2-(diphenylmethoxy)ethylamine, heated under stirring to completely dissolve, and then placed at 10°C- Crystallize at 20°C, filter, and vacuum-dry at 50°C to obtain 3.75 g of white crystalline doxylamine succinate with a melting point of 105.2-106.0°C and a content of 99.8%.

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Abstract

The present invention provides a method for preparing high-purity doxylamine succinate by adding an auxiliary alkali in a doxylamine succinate crude product re-crystallization process. According to the present invention, the method has characteristics of simple operation, economy and environmental protection, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation method of an antihistamine drug doxylamine succinate. technical background [0002] Doxylamine is a fast-acting, short-lasting antihistamine drug, its chemical name is N, N-dimethyl-2-[1-phenyl-1-(2-pyridyl) ethyl Oxygen] ethylamine, structural formula is as follows: [0003] [0004] Clinically, its succinate can be used alone as a drug to improve sleep, and it is also commonly used in compound cold medicine as an ingredient to relieve symptoms such as nasal congestion, which has important clinical value. [0005] The synthesis of this compound has been reported in literature, such as Chinese patents CN102108059A, CN 103524403A, CN 103467365, etc. [0006] The United States Pharmacopoeia (such as USP35) stipulates that the melting point of doxylamine succinate should be 103~108°C, and the content should be 98.0~101.0%. The European Pharmacopoeia (such as EP7.0) stipulates that the melting point of doxylamine...

Claims

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Application Information

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IPC IPC(8): C07D213/30C07C55/10C07C51/41
CPCC07D213/30
Inventor 陈婷婷陈华明赵坚沈雨婧
Owner NANJING NONGKANG BIOTECH CO LTD
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